AMENDED & RESTATED LICENSE AND DEVELOPMENT AGREEMENT\ By and Between OMNIPHARM LIMITED and FIDOPHARM, INC.
Portions
herein identified by ** have
been
omitted pursuant to a request for
confidential
treatment and have been
filed
separately with the Commission
pursuant
to Rule 24b-2 of the Exchange
Act
of 1934, as amended.
AMENDED
& RESTATED LICENSE AND DEVELOPMENT AGREEMENT\
By
and
Between
OMNIPHARM
LIMITED and
FIDOPHARM,
INC.
TABLE
OF CONTENTS
|
Page
|
|||
|
INDEX
|
|||
|
1.
|
DEFINITIONS
|
1
|
|
|
2.
|
LICENSE
GRANT AND OTHER RIGHTS
|
4
|
|
|
2.1
|
Exclusive
License.
|
4
|
|
|
2.2
|
Right
of Reference
|
||
|
2.3
|
Copyrighted
Materials
|
4
|
|
|
2.4
|
Exclusive
Right of First Negotiation
|
4
|
|
|
3.
|
CONSIDERATION
|
5
|
|
|
3.1
|
Upfront
Payment
|
5
|
|
|
3.2
|
Supply
Agreement
|
||
|
3.3
|
No
Additional Consideration
|
5
|
|
|
4.
|
DEVELOPMENT
|
5
|
|
|
4.1
|
Overview
|
5
|
|
|
4.2
|
Development
Plan.
|
5
|
|
|
4.3
|
Diligence
|
5
|
|
|
4.4
|
Reporting
and Data.
|
5
|
|
|
4.5
|
Compliance
with Laws
|
6
|
|
|
4.6
|
Access
to Records and Facilities
|
6
|
|
|
4.7
|
Territory
Specific Development
|
6
|
|
|
5.
|
PRODUCT
REGISTRATION AND COMMERCIALIZATION
|
6
|
|
|
5.1
|
Product
Registration
|
6
|
|
|
5.2
|
Registration
and Commercialization Plans
|
7
|
|
|
5.3
|
Trademarks
|
7
|
|
|
5.4
|
Cooperation
|
7
|
|
|
5.5
|
Reporting
|
7
|
|
|
6.
|
SUPPLY
OF PRODUCTS.
|
7
|
|
|
6.1
|
Supply
Agreement
|
7
|
|
|
6.2
|
Technology
Transfer
|
7
|
|
|
7.
|
PATENTS
|
7
|
|
|
7.1
|
Prosecution
and Maintenance of Patents
|
7
|
|
|
7.2
|
Notification
of Infringement
|
8
|
|
|
7.3
|
Enforcement
Against Third Parties.
|
8
|
|
|
7.4
|
Alleged
Infringement of Third Party’s Patents
|
8
|
|
|
8.
|
REPRESENTATIONS,
WARRANTIES AND COVENANTS.
|
9
|
|
|
8.1
|
Omnipharm
Representations, Warranties and Covenants
|
9
|
|
|
8.2
|
Fidopharm
Representations and Warranties
|
10
|
|
TABLE
OF CONTENTS
(continued)
|
Page
|
|||
|
8.3
|
Regulatory
Cooperation
|
11
|
|
|
8.4
|
Compliance
with Laws
|
11
|
|
|
9.
|
CONFIDENTIALITY
|
12
|
|
|
9.1
|
Confidentiality;
Nondisclosure; Nonuse
|
12
|
|
|
9.2
|
Exception
to Confidential Information
|
12
|
|
|
9.3
|
Notification
of Mandatory Disclosure
|
12
|
|
|
9.4
|
Patent
Application Filing
|
12
|
|
|
9.5
|
Permitted
Disclosure to Third Parties
|
12
|
|
|
10.
|
INDEMNIFICATION
AND INSURANCE
|
13
|
|
|
10.1
|
Omnipharm’s
Indemnification Obligations
|
13
|
|
|
10.2
|
Fidopharm’s
Indemnification Obligations
|
13
|
|
|
10.3
|
Indemnification
Procedure.
|
13
|
|
|
10.4
|
Insurance
|
14
|
|
|
11.
|
TERM
AND TERMINATION
|
14
|
|
|
11.1
|
Term
|
14
|
|
|
11.2
|
Termination
by Fidopharm
|
14
|
|
|
11.3
|
Termination
for Breach
|
14
|
|
|
11.4
|
Termination
for Bankruptcy, etc
|
14
|
|
|
11.5
|
Termination
for Failure
|
15
|
|
|
11.6
|
Effect
of Expiration or Termination.
|
15
|
|
|
12.
|
INJUNCTIVE
RELIEF AND DISPUTE RESOLUTION
|
16
|
|
|
12.1
|
Equitable
Relief
|
16
|
|
|
12.2
|
Dispute
Resolution
|
16
|
|
|
13.
|
MISCELLANEOUS
|
16
|
|
|
13.1
|
Force
Majeure
|
16
|
|
|
13.2
|
Further
Assurances
|
16
|
|
|
13.3
|
Assignment
|
17
|
|
|
13.4
|
Choice
of Law
|
17
|
|
|
13.5
|
Notices
|
17
|
|
|
13.6
|
Entire
Agreement
|
17
|
|
|
13.7
|
Amendments;
Waivers
|
18
|
|
|
13.8
|
Severability
|
18
|
|
|
13.9
|
Independent
Contractors
|
18
|
|
|
13.10
|
Counterparts
|
18
|
|
|
13.11
|
Headings
|
18
|
|
ii
AMENDED
& RESTATED LICENSE AND DEVELOPMENT AGREEMENT
THIS AMENDED & RESTATED LICENSE
AND DEVELOPMENT AGREEMENT (“Agreement”) is made as of this
22nd day of April 2008 (“Effective Date”), by and
between: Omnipharm Limited, a company having offices at Century House, 15 / 17
Musters road, ▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇, ▇▇ (“Omnipharm”), and Fidopharm, Inc., a
company having offices ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇ (“Fidopharm”). Fidopharm
and Omnipharmare together referred to as “Parties” and individually as
a “Party”.
RECITALS
WHEREAS, Omnipharmis
developing ACI-based products for manufacture and commercialization for
veterinary or animal application uses.
WHEREAS, the largest market in
the world for ACI-based products for veterinary or animal application uses is
the United States.
WHEREAS, the Parties agree that
Fidopharm has the requisite expertise and infrastructure to register and
commercialize veterinary products in the United States.
WHEREAS, Omnipharmdesires to
grant Fidopharm an exclusive license to use its know-how and under its patent
rights to, use, make, have made, market, offer for sale, import or export and
sell ACI-based products for veterinary or animal application use in the United
States, and Fidopharm desires to obtain such license.
AND WHEREAS, Omnipharmshall
cause the JV to execute a supply agreement contemporaneously with the execution
of this Agreement providing for the exclusive supply of Products to Fidopharm
for sale and distribution in the Territory.
NOW, THEREFORE, in
consideration of the mutual promises set forth herein, the Parties, intending to
be legally bound, hereby agree as follows:
|
1.
|
DEFINITIONS
|
As used
herein, the following terms shall have the respective meanings set forth
below:
1.1 “ACI” means (a) Active A
and/or (b) Active B.
1.2 “Active A” shall have the
meaning on Schedule
1.
1.3 “Active B” shall have the
meaning on Schedule
1.
1.4 “Affiliate” means any
individual, corporation, company, partnership, trust, limited liability company,
association or other business entity (“Person”) which directly or
indirectly controls, is controlled by or is under common control with the Party
in question. As used in this definition of “Affiliate,” the term
“control” shall mean, as to any Person, (a) direct or indirect ownership of
fifty percent (50%) or more of the voting interests or other ownership interests
in the Person in question (or such lesser percentage which is the maximum
allowed to be owned by such Person in a particular jurisdiction); (b) direct or
indirect ownership of fifty percent (50%) or more of the interest in the income
of the Person in question; or (c) possession, directly or indirectly, of the
power to direct or cause the direction of management or policies of the Person
in question (whether through ownership of securities or other ownership
interests, by contract or otherwise). Notwithstanding the foregoing,
the owners of preferred stock (or common stock issued upon conversion thereof)
of a Party such as financial institutions, venture capital funds and private
equity investors will not be its “Affiliates” for purposes of this
Agreement.
1
1.5 “Commercial Sale” means sale
of Products by Fidopharm or its Affiliates to a Third Party in the Territory,
other than distribution in connection with clinical trials of Products conducted
by Fidopharm.
1.6 “Confidential Information”
means all secret or confidential proprietary information or data of a Party
provided in written, oral, graphic, video, computer, electronic or other form to
the other Party.
1.7 “Controlled” means, with
respect to any intellectual property right or other intangible property, the
possession by license or ownership by a Party (or by an Affiliate) to grant to
the other Party access or a license or sublicense as provided herein without
violating the terms of any written contract with any Third Party.
1.8 “Development” means research
and chemical development activities, including without limitation toxicology,
test method development and stability testing, process development, formulation
development, delivery system development, quality assurance and quality control
development, statistical analysis, efficacy studies, product performance
studies, environmental impact studies, manufacturing process development and
scale-up, regulatory affairs, and product approval and regulatory activities
other than filing for and seeking Product Registrations.
1.9 “Field” means any and all
veterinary or animal application uses.
1.10 “JV” means ** Limited, which
shall be the entity responsible for supplying Products to
Fidopharm.
1.11 “Know-How” means any
proprietary technical or other information relating to Products and the make,
use or sale of Products, including technology, experience, formulae, concepts,
discoveries, trade secrets, inventions, modifications, improvements, data
(including all chemical, clinical, toxicological, analytical, and quality
control data), results, designs, ideas, analyses, methods, techniques, assays,
research plans, procedures, tests, processes (including manufacturing processes,
specifications and techniques), laboratory records, reports, summaries, and
information contained in submissions to, and information received from,
regulatory authorities, that are Controlled by Omnipharm, its Affiliates, JV or
Manufacturer as of the Effective Date or during the Term.
1.12 “Law” or “Laws” means the laws,
statutes, rules, codes, regulations, orders, judgments and/or ordinances of any
governmental authority (including without limitation the Regulatory
Authority).
1.13 “Manufacturer” shall have the
meaning set forth in Schedule 1, which
shall be amended upon the mutual agreement of the Parties.
1.14 “Patents” means (a) the
patents and patent applications listed in Schedule 2, (b) all
patents and patent applications related to Products that may be obtained,
including the make, use or sale of Products and (c) all patents and patent
applications which are divisions, continuations, continuations-in-part,
reissues, renewals, re-examinations, foreign counterparts, substitutions or
extensions of or to any patent applications or patents described in clauses (a)
or (b) of this sentence, that are Controlled by Omnipharm, its Affiliates, JV or
Manufacturer as of the Effective Date or during the Term. The Parties
hereby acknowledge that there are no Patents as of the Effective Date; provided,
that upon the filing of a Patent application Omnipharm shall create a Schedule 2 which
shall be updated as necessary.
1.15 “Products” means any product
containing ACI as its active chemical ingredient and which is covered by Patents
and/or uses Know-How, including, but not limited to the following
Products:
2
(a) “Product A” means a product
Developed by Omnipharm(including by any Affiliate of Omnipharmor by any Third
Party (on behalf of Omnipharmor its Affiliates)) meeting the specifications set
forth in Schedule
1; and
(b) “Product B” means a product
Developed by Omnipharm(including by any Affiliate of Omnipharm or by any Third
Party (on behalf of Omnipharm or its Affiliates)) meeting the specifications set
forth in Schedule
1.
1.16 “Product Registration” means,
with respect to a Product in a particular country or territory, the registration
or regulatory approval granted by the applicable governmental authority in such
country or territory allowing for such Product to be marketed, distributed, sold
or imported there.
1.17 “Regulatory Authority” means
the United State’s agency with jurisdiction over Products.
1.18 “Specifications” means, with
respect to a Product, the specifications for such Product set forth in the
Product Registration or as otherwise agreed to by the Parties.
1.19 “Supply Agreement” means that
Amended & Restated Manufacture and Supply Agreement entered into with the JV
contemporaneously with this Agreement.
1.20 “Territory” means the United
States and all of its states, territories and protectorates.
1.21 “Third Party” means any entity
or person other than Omnipharm or Fidopharm or their respective
Affiliates.
1.22 “Unit” means a ** of
Product.
1.23 Additional
Definitions. Each of the following definitions is set forth in
the Section of this Agreement indicated below:
|
Definition
|
Section
|
|
|
Agreement
|
Preamble
|
|
|
Copyrighted
Materials
|
2.3
|
|
|
Costs
|
11.5
|
|
|
Development
Data
|
4.4(b)
|
|
|
Development
Plan
|
4.2(a)
|
|
|
Effective
Date
|
Preamble
|
|
|
Fidopharm
|
Preamble
|
|
|
Force
Majeure
|
13.1
|
|
|
Indemnifying
Party
|
10.3
|
|
|
Initial
Products
|
4.1
|
|
|
Initial
Term
|
11.1
|
|
|
Omnipharm
|
Preamble
|
|
|
Parties
|
Preamble
|
|
|
Party
|
Preamble
|
|
|
Person
|
1.1
|
|
|
Registration
and Commercialization Plan
|
5.2
|
|
|
ROFN
Notice
|
2.4
|
|
|
Term
|
11.1
|
|
|
Territory
Development
|
4.7
|
|
|
Territory
Development Costs
|
4.7
|
|
|
Third
Party-Patent Infringement Notice
|
7.4
|
|
|
Trademark
|
5.3
|
3
|
2.
|
LICENSE
GRANT AND OTHER RIGHTS
|
2.1 Exclusive
License.
(a) Subject
to the terms and conditions of this Agreement, Omnipharm hereby grants Fidopharm
an exclusive license, with a right to sublicense, to use the Know-How and under
the Patents to, use, make, have made, market, offer for sale and import or
export Products in the Field in the Territory. For clarity,
Fidopharm’s right to export hereunder shall not include the right to export
Product to end-users or commercial distributors outside of the
Territory.
(b) Notwithstanding
the license grant above, Fidopharm shall not make or have Products made and
supplied (other than through the JV) for Commercial Sale in the Territory unless
there as been a Failure (as defined in the Supply Agreement).
2.2 Right of Reference. Omnipharm
hereby grants Fidopharm the right to access, reference and use all data
and regulatory filings (including all Product Registrations Controlled by
Omnipharm, its Affiliates, JV and Manufacturer) and regulatory communications
associated with any submissions for the Products to the extent permitted under
applicable Laws. Where required in order for Fidopharm to obtain such
access, Omnipharm shall or shall cause the appropriate party to, as soon as
reasonably possible (and in any event no later than thirty (30) days from the
date of Fidopharm’s request), provide the applicable governmental authority with
notice of its consent to such access by Fidopharm in the appropriate
form. In the event that Omnipharm grants any Third Party any rights
in Products, (i) Omnipharm shall use its best efforts to ensure that any such
Third Party will grant Omnipharm a right to access, reference and use any and
all data and regulatory filings related to Products and (ii) Omnipharm hereby
grants Fidopharm a right to access, reference and use any and all data and
regulatory filings related to Products which Omnipharm has such a right to
access; provided, that in any event Omnipharm shall ensure that any such Third
Party shall be subject to safety and adverse event reporting obligations no less
stringent than the terms and conditions contained in Section 8.3 and Fidopharm shall be made aware of any such
safety or adverse events within twenty-four (24) hours of Omnipharm being
informed of such an event. Omnipharm reserves the right to use such data
worldwide in support of any registration held by it or a Third Party
partner.
2.3 Copyrighted
Materials. To the extent that Omnipharm develops or has
developed any manuals, logos, and other copyrighted works for use with Products
(individually and collectively, the “Copyrighted Materials”),
Omnipharm hereby grants Fidopharm a royalty-free, non-exclusive license to use
and distribute such Copyrighted Materials in connection with marketing,
promoting, selling or importing Products in the Field in the
Territory.
2.4 Exclusive Right of First
Negotiation. Prior to Omnipharm granting to a Third Party a
license or similar right (including a co-promotion right or an option to acquire
such license or right) to market, offer for sale, import or export one (1) or
more products containing ACI (other than Products) in the Field in the
Territory, it shall so advise Fidopharm in writing (an “ROFN
Notice”). Upon request by Fidopharm within thirty (30) days
after its receipt of the ROFN Notice, Omnipharm and Fidopharm shall discuss the
terms and conditions under which Omnipharm would grant to Fidopharm rights to
market, offer for sale, import or export such products in the Field in the
Territory. If the Parties agree to grant such rights to Fidopharm,
including the terms and conditions of such grant, the Parties shall prepare and
execute an amendment to this Agreement incorporating such additional rights and
terms. If Fidopharm does not so request within the thirty (30) day
period after its receipt of the ROFN Notice, or if the Parties do not agree in
writing on the terms of such additional grant of rights to Fidopharm within
ninety (90) days after the date of the ROFN Notice to Fidopharm, Omnipharm shall
be free to grant to one or more Third Parties the right to market, offer for
sale, import or export such products in the Field in the Territory, on such
terms as Omnipharm considers appropriate.
4
|
3.
|
CONSIDERATION
|
3.1 Upfront Payment. In
partial consideration of the grant of rights under this Agreement and
Omnipharm’s obligations to conduct the Development activities provided
hereunder, Fidopharm shall pay Omnipharm an upfront payment of five hundred
thousand dollars (US$500,000) within fourteen (14) days of the Effective
Date.
3.2 Supply
Agreement. As further consideration of the grant of rights
under this Agreement and its obligations to conduct the Development activities
provided hereunder, Fidopharm shall contemporaneously with this Agreement enter
into the Supply Agreement.
3.3 No Additional Consideration.
Omnipharm shall be entitled to no additional consideration for the grant of
rights to Fidopharm under this Agreement and Omnipharm’s obligations to conduct
the Development activities other than as provided under this Article 3 and Section 4.7
below.
|
4.
|
DEVELOPMENT
|
4.1 Overview. Omnipharm
shall be primarily responsible, at its sole cost except as otherwise
specifically provided herein, for designing and conducting all Development
activities necessary to receive Product Registrations for the Product A and
Product B (together, the “Initial Products”) in
accordance with the Development Plan. Fidopharm shall be responsible,
at its sole cost, for submitting the Product Registrations to the Regulatory
Authority.
4.2 Development
Plan.
(a) The
Development of the Initial Products shall be governed by a development plan (the
“Development
Plan”). The initial Development Plan shall be attached hereto
as Schedule
4.2. The Development Plan shall include options for
‘essentially similar’ and complete clinical package registration data routes
with costings, timelines, stage payments, ** and other elements to be set forth
in the Development Plan.
(b) The
Development Plan, together with any updates thereto, shall be prepared and
approved as follows from time to time during the Term, each Party shall have the
right to propose amendments to and amend the existing Development Plan;
provided, that in any event Omnipharm shall present Fidopharm an updated
Development Plan at least once per calendar year for its review and approval,
not to be unreasonably withheld or delayed. Fidopharm shall have a
period of twenty-one (21) days from the date that the updated Development Plan
is received to provide its approval. If approval or rejection is not
provided to Omnipharm within such twenty-one (21)-day period, then the
Development Plan shall be deemed approved. For purposes of clarity,
no change to the Development Plan shall be made without the prior written
approval of both Parties.
4.3 Diligence. Omnipharm
shall carry out the Development activities, in strict accordance with the
Development Plan and the timelines set forth therein, necessary for obtaining
the Product Registrations as set forth in this Agreement, including generating
any additional data necessary to obtain Product Registration specifically for
the Territory at Fidopharm’s instruction. Fidopharm shall file the Product
Registrations in accordance with the Registration and Commercialization Plan
based on the data provided by Omnipharm.
4.4 Reporting
and Data.
(a) Upon
request, Omnipharm shall promptly, but in no event later than thirty (30) days
after such request provide Fidopharm with (i) a summary in reasonable detail of
all data generated or obtained from each discrete Development activity performed
under the Development Plan, such as any toxicology study, pharmacokinetics study
or stability study, (ii) a summary of the Development progress against the
projected Development progress set forth in the current Development Plan and
(iii) a final report of the results of each Development activity, together with
all material supporting data.
5
(b) Omnipharm
shall provide Fidopharm copies of all substantive or material information with
respect to the Development of Products, including clinical data compiled with
respect to Products and all information and data filed with any governmental
authority with respect to Products outside of the Territory, as soon as
reasonably practicable after such information, data or results become available
to or compiled by Omnipharm, including any drafts and final versions of any
study reports (the “Development
Data”). Subject to the terms and conditions of this Agreement,
Fidopharm shall have the right to use the Development Data or any portion
thereof for the purpose of obtaining Product Registrations and commercializing
Products in the Territory.
4.5 Compliance with Laws.
Omnipharm or its agents shall perform its responsibilities under this
Article 4, including those set forth in the Development Plan, in accordance with
all applicable Laws.
4.6 Access to Records and
Facilities. Omnipharm shall maintain scientific records, in
sufficient detail and in good scientific manner appropriate for obtaining
Patents and regulatory purposes, which shall fully and properly reflect all work
done and results achieved in the performance of Development under this
Agreement. Fidopharm shall be entitled to have access during regular
business hours and upon reasonable advance notice, to Omnipharm’s records and
facilities relating to the Development of Products for the purpose of monitoring
compliance with all applicable Laws and other applicable regulatory
requirements. In all Third Party agreements involving the Development
of Products, Omnipharm shall require that the Third Parties thereto provide
Omnipharm with access to such Third Party facilities and all such data generated
by Third Parties. Fidopharm shall have the right to inspect such
facilities on behalf of Omnipharm in the event that:
(a) a
specific concern is raised regarding Product by any governmental authority
(including the Regulatory Authority);
(b) a
routine inspection/audit for Regulatory Authority purposes;
(c) a
routine inspection to confirm compliance with the terms of this Agreement,
including without limitation, the progress of Product Development;
or
(d) a
routine inspection/audit for a Fidopharm customer.
For
clarity, inspection and audits pursuant to Section 4.6(d) shall be limited to
two (2) separate visits in any twelve (12) month period for each specific Third
Party; provided, that additional reasonable inspections/audits shall be
permitted upon Fidopharm obtaining Omnipharm’s prior consent, which shall not be
unreasonably withheld, conditioned or delayed. All inspection/audit
costs shall be borne by the Party incurring such costs.
4.7 Territory Specific
Development. To the extent that additional Development is
necessary solely to obtain the Product Registration in the Territory (“Territory Development”),
Omnipharm shall supplement the current Development Plan with a budget setting
forth the reasonable costs for conducting the Territory Development specific
activities (“Territory
Development Costs”) and shall submit such supplement to Fidopharm for its
consent and upon approval of such Territory Development Costs by Fidopharm,
Fidopharm shall reimburse such costs as they are incurred.
|
5.
|
PRODUCT
REGISTRATION AND COMMERCIALIZATION
|
5.1 Product
Registration. Fidopharm shall, at its sole expense, use
commercially reasonable efforts to obtain and maintain Product Registrations in
accordance with the Registration and Commercialization
Plan. Fidopharm shall be the sole owner of all Product Registrations
in the Territory. For clarity, Fidopharm shall have the sole right in
determining whether or not to obtain and/or maintain any specific Product
Registration in the Territory.
6
5.2 Registration and Commercialization
Plans. No less than thirty (30) days prior to first Commercial
Sale Fidopharm shall provide an annual development plan for its activities in
order to obtain Product Registrations and after first Commercial Sale Fidopharm
shall provide an annual commercialization plan for its efforts to commercialize
Products (the “Registration and
Commercialization Plan”). Fidopharm shall update the
Registration and Commercialization Plan annually and shall provide such updated
plan to Omnipharm not later than thirty (30) days before start of each
year. The Registration and Commercialization Plan description shall
be agreed between the Parties.
5.3 Trademarks. Fidopharm
shall have the sole right to determine the trademark(s) or trade name(s) that
Fidopharm shall adopt for use with Products (the “Trademark”). All
goodwill generated through the use of Trademarks by Fidopharm shall inure to the
benefit of Fidopharm. Fidopharm shall own all Trademarks and shall
register and maintain such Trademarks at its sole cost and
discretion.
5.4 Cooperation. Omnipharm
shall provide (a) reasonable cooperation and support to Fidopharm in connection
with maintenance of the Product Registration and (b) all information (including
Confidential Information) that is reasonably required for the Development and/or
commercialization of Products. Subject to Article 9, Fidopharm may use such Confidential Information
solely for the purpose of Developing and commercializing Products.
5.5 Reporting. Each
Party shall keep the other Party informed of developments known by it that would
reasonably be expected to have a material adverse effect on any Product or
Product Registration, including, but not limited to, the general regulatory
strategy for Products in the Territory.
|
6.
|
SUPPLY
OF PRODUCTS.
|
6.1 Supply
Agreement. Contemporaneously with the execution of this
Agreement Fidopharm shall enter into the Supply Agreement with the
JV. Pursuant to the terms of the Supply Agreement, the JV shall
supply Fidopharm’s requirements of Products. Notwithstanding the
foregoing, as between Fidopharm and Omnipharm, in the event of a conflict
between the Supply Agreement and this Agreement, Fidopharm’s rights in regards
to the licenses (and any other intellectual property related to the Products)
and Product Registrations related to the Products shall be governed solely by
the terms of this Agreement.
6.2 Technology
Transfer. In the event that there is a Failure (as defined in
the Supply Agreement) or if this Agreement is terminated pursuant to Section
11.2(b), 11.3 or 11.4, (a) the restrictions set forth in Section 2.1(b) of
this Agreement shall no longer be applicable (which for clarity, means that
Fidopharm shall have the right to manufacture, or have manufactured, Product
itself or by a Third Party) and (b) Omnipharm shall undertake, and/or, as
necessary, cause the JV and Manufacturer to undertake, an immediate transfer to
Fidopharm or its designee of all technology and Know-How necessary, useful or
used to manufacture Products. Omnipharm shall also make available, or
cause to be made available any individuals who may be useful implementing the
manufacturing processes related to Products.
|
7.
|
PATENTS
|
7.1 Prosecution and Maintenance of
Patents. Omnipharm will prosecute and maintain the Patents at
its sole cost in the Territory, using counsel of its choice reasonably
acceptable to Fidopharm and shall not abandon any Patent without the prior
written consent of Fidopharm. During the Term, Omnipharm pursuant to
this Section 7.1 shall copy Fidopharm, or have Fidopharm copied, on all material
or substantive documents regarding Patents, which are received from or to be
filed in any patent office in the Territory, promptly following receipt from the
patent office and within a reasonable time prior to filing with the patent
office (but not less than thirty (30) days), as applicable, including copies of
each patent application, office action, response to office action, declaration,
information disclosure statement, request for terminal disclaimer, request for
patent term extension and request for reexamination. Fidopharm shall
have the right to comment on the prosecution of such Patents and provide such
comments to Omnipharm’s patent counsel, and Omnipharm shall consider all such
comments in good faith. For the purposes of this Section 7.1, “prosecute and
maintain” means, with respect to a patent, the preparing, filing,
prosecuting and maintenance of such patent, as well as re-examinations, reissues
and requests for patent term extensions and the like with respect to such
patent, together with the conduct of interferences, the defense of oppositions
and other similar proceedings and appeals thereof with respect to a patent, but
shall not include enforcement litigation or the defense of declaratory judgment
actions. Also, as used in this Section 7.1, to “abandon” particular
Patent shall include deciding not to defend against an opposition, not to defend
an interference or similar proceeding, not to pursue an appeal of an adverse
decision or not to pursue particular claims, in each case with respect to such
Patent in the United States Patent & Trademark Office.
7
7.2 Notification of
Infringement. The Parties shall promptly inform each other of
any information that comes to their attention involving (a) actual or apparent
infringements or misappropriations of the Patents, by any Third Party in the
Territory, or (b) claims of alleged infringement made by any Third Party against
either Party or its respective Affiliates or sub-licensees resulting from the
Development, manufacture, import, offer for sale, sale or use of
Products.
7.3 Enforcement
Against Third Parties.
(a) Notice. If either
Party reasonably believes that a Third Party is conducting any activities in the
Territory that may constitute actual or potential infringement of the Patents,
such Party shall promptly notify the other Party of such
activities.
(b) Fidopharm’s First Right to
Enforce. Except as otherwise agreed, Fidopharm shall have the
first right to bring and control any action or proceeding under such Patents in
respect to an alleged infringement occurring in the Territory. If
Fidopharm fails to bring an action or proceeding with respect to an alleged
infringement occurring in the Territory within one-hundred-twenty (120) days
following a request by Omnipharm to do so, Omnipharm shall have the right to
bring and control any such action or proceeding with respect to such
Patents.
(c) Cooperation. The
Parties shall reasonably cooperate with each other in all actions or proceedings
described in this Section 7.3, to the extent
pertaining to an alleged infringement. The non-controlling Party
agrees to be joined as a party plaintiff if necessary to prosecute the action or
proceeding and shall provide all reasonable cooperation (including any necessary
use of its name) required to prosecute such litigation; provided that the
controlling Party shall reimburse the non-controlling Party for out-of-pocket
expenses reasonably incurred in providing such cooperation at the controlling
Party’s request. The non-controlling Party will be entitled to be
represented by counsel of its own choice at its own expense.
(d) Recoveries. Any
recovery obtained by any Party as a result of any proceeding described in this
Section 7.3, by settlement or otherwise, shall be
applied in the following order of priority: (i) first, to reimburse each Party
for all litigation costs in connection with such proceeding paid by that Party
and not otherwise recovered (on a pro rata basis based on each Party’s
respective litigation costs, to the extent the recovery was less than all such
litigation costs); and (ii) second, the remainder shall be kept by the
controlling Party.
7.4 Alleged Infringement of Third Party’s
Patents. In the event that either Party is named as a
defendant in any legal or other action or proceeding, including any settlement
or negotiation, or learns of any threatened action or proceeding with respect to
any alleged infringement of a Third Party patent or other proprietary right as a
result of Developing, manufacturing, importing, offering for sale, selling or
using Products such Party will promptly notify the other Party in writing (a
“Third Party-Patent
Infringement Notice”). The Parties will closely coordinate
regarding any infringement, or alleged infringement, of Third Party rights
related to Products; provided, that in the Territory, Fidopharm shall have the
first right but not the obligation to defend any action brought by, or negotiate
a settlement with, a Third Party claiming any infringement or potential
infringement by Products of such Third Party’s rights. In the event
that Fidopharm elects not to, or fails to, initiate any defense or settlement
within one-hundred-twenty (120) days following its receipt of a Third
Party-Patent Infringement Notice, Omnipharm shall have the right to take such
steps as may be considered necessary or appropriate by Omnipharm to defend such
infringement claim. Each Party shall render such reasonable
assistance as may be requested by the defending Party in connection with such
infringement actions. If one Party requests the other Party’s
reasonable assistance in connection with such infringement claims or actions,
the requesting Party shall reimburse the other Party for such direct,
out-of-pocket expenses as are reasonably incurred during the course of its
providing such requested assistance.
8
|
8.
|
REPRESENTATIONS,
WARRANTIES AND COVENANTS.
|
8.1 Omnipharm Representations, Warranties
and Covenants. Omnipharm hereby represents, warrants and
covenants to Fidopharm as follows:
(a) The
execution and delivery by Omnipharm of this Agreement and the performance by
Omnipharm of its obligations hereunder have been duly authorized by all
necessary corporate action on the part of Omnipharm, and do not conflict with
the terms of any other contract, agreement, arrangement or understanding to
which Omnipharm is a party.
(b) Except
as set forth herein, no consent, approval, order or authorization of, or
registration, qualification, designation, declaration or filing with, any
federal, state or local governmental authority is required on the part of
Omnipharm in connection with the valid execution, delivery and performance of
this Agreement.
(c) Omnipharm
is and will be in compliance through the term of this Agreement in all material
respects with all Laws applicable to its performance under this
Agreement.
(d) There
is no action or proceeding pending or threatened against Omnipharm that
questions the validity of this Agreement or any action taken by Omnipharm in
connection with the execution of this Agreement.
(e) In
regards to intellectual property:
(i) Omnipharm
has not knowingly infringed any Third Party patent rights in developing
Products. In the event that Omnipharm becomes aware of any Third
Party patents rights being infringed, or potentially being infringed, by the
development, manufacture or commercialization of a Product, Omnipharm shall
notify Fidopharm of such infringement or potential infringement within
twenty-four (24) hours of gaining such knowledge.
(ii) as
of the Effective Date, there are no pending proceedings in any court or
arbitration, administrative or other tribunal which are concerned with the
validity or ownership of any of the Patents or Know-How. Without
derogation from the foregoing, there are no oppositions, revocation,
cancellation, invalidation or rectification proceedings pending in relation to
any of the Patents or Know-How in any court. No Third Party has
notified Omnipharm or any Omnipharm Affiliate of its intention to bring any such
proceedings.
(iii) Omnipharm
has not and no Omnipharm Affiliate has received any written complaints or
threats and there are no pending proceedings or claims, alleging that the
exploitation of the Patents or Know-How infringe or would infringe the
intellectual property rights of any Person;
(iv) Details
of the Patents are set out in Schedule 2 and all
the details are correct. Without derogation from the generality of
the foregoing, the Patents are subsisting and all applications for Patents
indicated in Schedule
2 as pending are pending. The legal and beneficial owner or
applicant for registration of each of the Patents specified in Schedule 2 is
correctly stated;
9
(v) The
Patents and Know-How are the only intellectual property rights owned by,
licensed to or used by Omnipharm or its Affiliates in relation to Products and
to the best of Omnipharm’s knowledge no intellectual property rights other than
the Patents or Know-How are required in order to Develop, manufacture, use,
import and/or sell or commercialize Products in the Territory;
(vi) All
actions required to be taken before the Effective Date for the prosecution and
maintenance of the Patents (including all applicable fees due and payable before
such date) have been taken or paid; and
(vii) The
Patents are not and, during the Term, will not become subject to any encumbrance
or lien in favor of any Third Party that is inconsistent with or otherwise
restricts the rights and sublicenses granted to Fidopharm
hereunder.
(f) In
regards to Development:
(i) Omnipharm
covenants that **
(ii) All
trials related to Products have been carried out and will be carried out in
accordance with all relevant Laws;
(iii) Neither
Omnipharm nor any Omnipharm Affiliate is engaged in any litigation, opposition
or arbitration proceedings affecting or relating to Products, the Patents,
Know-How (including but not limited to claims relating to product liability) as
plaintiff or defendant and there are no such proceedings pending or threatened
by or against Omnipharm or any Omnipharm Affiliate and Omnipharm is not aware of
facts or circumstances likely to give rise to any such proceedings;
and
(iv) No
injunction has been granted against Omnipharm or its Affiliates in connection
with Products, the Patents or Know-How.
(g) Neither
Omnipharm or any Omnipharm Affiliate has nor will provide (directly or
indirectly) any Third Party access or rights to use its Know-How (including,
without limitation, use of any data or under any Patents) for Development,
regulatory approval or commercialization of any product containing Active A at a
concentration range between ** and ** weight/volume.
(h) As
of the Effective Date, neither it nor its Affiliates has been debarred or is
subject to debarment and neither Omnipharm nor any of its Affiliates will use in
any capacity, in connection with the Development or commercialization of
Products, any Person who has been debarred pursuant to Section 306 of the United
States Federal Food, Drug and Cosmetic Act, or who is subject of a conviction
described in such section. Further, Omnipharm agrees to inform
Fidopharm in writing immediately if it or any Person who is performing services
hereunder is debarred or is the subject of a conviction described in Section
306, or if any action, suit, claim, investigation or legal administrative
proceeding is pending or, to the best of Omnipharm’s knowledge, is threatened,
relating to the debarment of Omnipharm, its Affiliates or any Person used in any
capacity by Omnipharm or its Affiliates in connection with the Development or
commercialization of Products.
8.2 Fidopharm Representations and
Warranties. Fidopharm hereby represents and warrants to
Omnipharm as follows:
(a) The
execution and delivery by Fidopharm of this Agreement and the performance by
Fidopharm of its obligations hereunder have been duly authorized by all
necessary corporate action on the part of Fidopharm, and do not conflict with
the terms of any other contract, agreement, arrangement or understanding to
which Fidopharm is a Party.
10
(b) Except
as set forth herein, no consent, approval, order or authorization of, or
registration, qualification, designation, declaration or filing with, any
federal, state or local governmental authority is required on the part of
Fidopharm in connection with the valid execution, delivery and performance of
this Agreement, where the failure to obtain any of the foregoing would not have
a material adverse impact on the ability of Fidopharm to meet its obligations
hereunder.
(c) Fidopharm
is and will be in material compliance throughout the Term with all of the
applicable Laws relating to Products in the Territory.
8.3 Regulatory
Cooperation.
(a) The
Parties shall disclose to each other all reports or other knowledge they receive
with respect to adverse experiences, and reports of mislabeling, stability
failures or microbiological contamination.
(b) In
addition to and without limiting the requirements of Section 8.3(a) above,
Fidopharm and Omnipharm agree, throughout the duration of this Agreement, to
notify the other Party immediately of any information concerning any serious or
unexpected side effect, injury, toxicity or sensitivity reaction, or any
unexpected incidents, and the severity thereof, associated with the clinical
uses, studies, investigations, tests and marketing of Products, whether or not
determined to be attributable to Products. Each Party shall cooperate
with the other to resolve any complaints received by either Party with respect
to Products.
(c) Each
of Fidopharm and Omnipharm shall promptly deliver to the other all material
correspondence that such Party may receive, directly or indirectly, from
regulatory authorities in jurisdictions where such Party (or its sublicensees,
distributors, or sub-distributors) has rights to market Products, except for
procedural, nonsubstantive communications which do not relate to the safety or
efficacy of Products. Fidopharm and Omnipharm shall also immediately
notify the other Party about any information such Party receives regarding any
threatened or pending action by a governmental agency that may affect the safety
and efficacy claims of Products or the continued marketing, promotion,
distribution, sale or manufacture of Products. Upon receipt of any
such information, the Parties shall consult in an effort to arrive at a mutually
acceptable procedure for taking appropriate action, provided that nothing
contained herein shall be construed as restricting either Party’s right to make
a timely report of such matter to any governmental or regulatory agency or take
other action that it deems to be appropriate or required by applicable law or
regulation. It is Fidopharm’s responsibility to report adverse events
in accordance with local Laws and requirements to governmental or regulatory
agencies in the Territory.
(d) Without
limiting the foregoing, it is also understood that each Party may notify any of
its Affiliates, licensees, distributors or sub-licensees of any incident or
event reported by either Party under this Section 8.3. In addition,
each Party shall, and shall require its respective Affiliates to: (i) to the
extent permissible under time constraints and reporting requirements, provide to
the other Party in advance of initial or periodic submission to the applicable
regulatory authorities any and all adverse event reports from clinical trials
and commercial experiences with Products; (ii) provide such adverse event
reports to the other Party contemporaneously with the provision of such reports
to the applicable regulatory authority; and (iii) adhere to all requirements of
applicable Laws which relate to the reporting and investigation of adverse
events and keep the other Party informed of such events. If a Party
contracts with a Third Party for any research to be performed by such Third
Party on Products, that Party shall require such Third Party to report to the
contracting Party the information set forth above.
8.4 Compliance with
Laws. Both Parties shall comply in all material respects with
all applicable Laws with respect to the supply, Development, testing, marketing,
promotion, storage, import, distribution and sale of Products.
11
|
9.
|
CONFIDENTIALITY
|
9.1 Confidentiality; Nondisclosure;
Nonuse. During the Term, and for ten (10) years after the
termination of this Agreement, each Party shall keep confidential the other
Party’s Confidential Information and, except as expressly permitted herein,
shall not disclose such Confidential Information to any Third Party in any
manner whatsoever, in whole or in part, without first obtaining the other
Party’s prior written consent to such disclosure. The standard of
care required of each Party in protecting the confidentiality of the other
Party’s Confidential Information shall be at least as strict as the same
standard of care that the receiving Party uses in protecting its own
Confidential Information, but in no event shall either Party use less than a
reasonable standard of care. Neither Party shall use any Confidential
Information of the other Party for any purpose other than to perform its
obligations under this Agreement or as otherwise authorized under this
Agreement. The receiving Party shall ensure that its employees,
representatives, and agents comply with this provision, and shall be responsible
for any breach by such employees, representatives, or agents.
9.2 Exception to Confidential
Information. The foregoing obligations of confidentiality,
nondisclosure and nonuse shall not apply to any Confidential Information (a)
which is now public knowledge or which hereafter becomes public knowledge
through no breach of this Agreement by the receiving Party; (b) which the
receiving Party received without restriction from an independent Third Party;
(c) which the receiving Party can demonstrate was already in its possession at
the time of receipt from the disclosing Party and not subject to another
agreement between the Parties; or (d) which the receiving Party can demonstrate
was independently developed by the receiving Party in the course of work by the
officers, directors, employees, consultants or agents of itself or of its
Affiliates, subsidiaries or related companies without the aid, use or
application of Confidential Information of the disclosing Party.
9.3 Notification of Mandatory
Disclosure. Each Party may use or disclose Confidential
Information of the other Party to the extent such use or disclosure is
reasonably necessary in complying with applicable Laws or required by
governmental authorities or pursuant to a court order or otherwise submitting
information to governmental authorities in connection with clinical trials or
applying for Product Registrations, negotiating or making a permitted sublicense
or otherwise exercising its rights hereunder; provided that if a Party is
required under applicable Laws or court order to make any such disclosure of the
other Party’s Confidential Information, it shall (i) give prompt written notice
to the disclosing Party of the proposed disclosure, and allow the disclosing
Party at least fourteen (14) business days to object to all or any portion of
the disclosure before it is disclosed; (ii) provide written notice of disclosure
immediately thereafter, if advance notice is not possible; (iii) minimize the
extent of such disclosure, to the extent possible; and (iv) seek confidential
treatment of such information prior to its disclosure, it being understood that
any information so disclosed shall otherwise remain subject to the limitations
on use and disclosure hereunder.
9.4 Patent Application
Filing. Notwithstanding anything to the contrary, if a
disclosing Party has not filed a necessary Patent application with respect to
any applicable Confidential Information, it may require the receiving Party to
delay the proposed authorized or required disclosure (to the extent the
disclosing Party may legally do so), for up to ninety (90) days, to allow for
the filing of such an application.
9.5 Permitted Disclosure to Third
Parties. Except as expressly permitted in this Agreement,
neither Party shall disclose this Agreement or any terms of this Agreement to
any Third Party without the prior written consent of the other Party; except
that such consent shall not be required for disclosure to actual or prospective
investors, collaboration partners or the other party in a proposed investment,
merger, acquisition or a similar transaction, or to a Party’s accountants,
attorneys and other professional advisors (provided that such disclosures shall
be subject to continued confidentiality obligations at least as strict as is set
forth herein). To the extent that either Party determines that it or
the other Party is required to file or register this Agreement or a notification
thereof to comply with the requirements of an applicable stock exchange or
NASDAQ regulation or any governmental authority, including without limitation
the U.S. Securities and Exchange Commission, such Party shall promptly inform
the other Party thereof. Prior to making any such filing,
registration or notification, the Parties shall agree on the provisions of this
Agreement for which the Parties shall seek confidential treatment, it being
understood that if one Party determines to seek confidential treatment for a
provision for which the other Party does not, then the Parties will use
reasonable efforts in connection with such filing to seek the confidential
treatment of any such provision. The Parties shall cooperate, each at
its own expense, in such filing, registration or notification, including without
limitation such confidential treatment request, and shall execute all documents
reasonably required in connection therewith.
12
|
10.
|
INDEMNIFICATION
AND INSURANCE
|
10.1 Omnipharm’s Indemnification
Obligations. Omnipharm shall indemnify and hold Fidopharm
harmless from and against any direct costs, expenses (including, without
limitation, reasonable attorneys’ fees) or damages which arise from breach by
Omnipharm of any of its representations, covenants, warranties or obligations
set forth herein, including, without limitation, any claims in connection with
(i) failure of Products supplied by Omnipharm to meet the Specifications, or
(ii) any breach of its representations, warranties or covenants hereunder,
except to the extent such damages are caused by or arise from (x) the gross
negligence or willful misconduct of Fidopharm; or (y) any matter as to which
Fidopharm has agreed to indemnify Omnipharm hereunder.
10.2 Fidopharm’s Indemnification
Obligations. Fidopharm shall indemnify and hold Omnipharm
harmless from and against any direct costs, expenses (including, without
limitation, reasonable attorneys’ fees) or damages which arise from the breach
by Fidopharm of any of its representations, covenants, warranties or obligations
set forth herein or from the marketing, sale or distribution of Products by
Fidopharm and its Affiliates, distributors and permitted sublicensees, except to
the extent such damages were caused by or arise from (i) the gross negligence or
willful misconduct of Omnipharm; or (ii) any matter as to which Omnipharm has
agreed to indemnify Fidopharm hereunder.
10.3 Indemnification
Procedure.
(a) Promptly
after the receipt by any Party hereto of notice of (a) any claim or (b) the
commencement of any action or proceeding, such Party shall, if a claim with
respect thereto is to be made against any Party obligated to provide
indemnification pursuant to Section 10.1 or 10.2 hereof (the “Indemnifying
Party”), give such Indemnifying Party written notice of such claim or the
commencement of such action or proceeding. Such Indemnifying Party
shall have the right, at its option, to compromise or defend, subject to Section
10.3(c) below, at its own
expense and by its own counsel, any such matter involving the asserted liability
of the Party seeking such indemnification. Such notice, and the
opportunity to compromise or defend, shall be a condition precedent to any
liability of the Indemnifying Party under the indemnification provisions of
Section 10.1 or 10.2. In the event
that any Indemnifying Party shall undertake to compromise or defend any such
asserted liability, it shall promptly notify the Party seeking indemnification
of its intention to do so, and the Party seeking indemnification agrees to
cooperate fully with the Indemnifying Party and its counsel in the compromise
of, or defense against, any such asserted liability. In any event,
the indemnified Party shall have the right, at its own expense, to participate
in the defense of such asserted liability, provided,
that the Indemnifying Party’s counsel shall make all final decisions concerning
the defense or, subject to Section 10.3(c) below, compromise or
settlement of such litigation.
(b) Each
of the Parties hereto shall be entitled to be represented at any proceedings
brought against the other Party under this Article 10 by its own counsel, at its
own expense, and shall cooperate fully with the other Party in any such
proceeding, provided it is
adequately reimbursed for its out-of-pocket costs and expenses, excluding
attorneys’ fees.
(c) Neither
Party may settle a claim described in this Article 10 in a manner which would
impose upon the other Party any monetary obligation or require such other Party
to submit to an injunction or otherwise limit its rights, in each case, without
the prior written consent of such other Party, which consent shall not be
unreasonably withheld, conditioned, or delayed.
13
10.4 Insurance. The
Parties shall each maintain insurance in amounts commercially reasonable for the
veterinary pharmaceutical industry commensurate with their rights and
obligations hereunder.
|
11.
|
TERM
AND TERMINATION
|
11.1 Term. The initial
term of this Agreement shall begin on the Effective Date and shall continue for
ten (10) years after the first Commercial Sale (the “Initial Term”) unless earlier
terminated pursuant to this Article 11. At the expiration of the
Initial Term, the term of this Agreement shall automatically renew for
successive five (5) year periods (the Initial Term and all such renewal periods,
the “Term”) unless
written notice of non-renewal is provided by Fidopharm to Omnipharm at least
sixty (60) days prior to the applicable renewal date.
11.2 Termination by
Fidopharm.
(a) Fidopharm
shall have the right to terminate this Agreement without cause and without
penalty upon ninety (90) days prior written notice to Omnipharm, provided, that
such period shall be extended for a reasonable period (not to exceed another
sixty (60) days) in order to effect the transfer of Product Registrations
pursuant to Section 11.6(e). For clarity, any early, without cause termination by
Fidopharm ahead of Product registration deems all fees / costs paid to Omnipharm
as not refundable. Should such a termination by Fidopharm occur
during the implementation of the Development Plan, Fidopharm shall be liable for
all reasonable non-cancelable ongoing costs, solely in regards to the Territory,
necessary to complete the then current Development activities; provided, that
Omnipharm shall immediately terminate such ongoing commitments as soon as
possible and shall not incur any non-necessary expenses in effectuating such
termination.
(b) In
the event that Fidopharm terminates the Supply Agreement pursuant to Section
12.2 or 12.3 therein, Fidopharm shall have the right to terminate this Agreement
immediately and without penalty upon written notice to Omnipharm.
11.3 Termination for
Breach. In the event of any material default by either Party
in the performance of any of the terms and conditions of this Agreement, the
other Party may terminate this Agreement upon ninety (90) days’ written notice;
provided that
(i) if during such ninety (90) day period the Party against whom the material
default is claimed cures such default, (ii) if such breach cannot be cured
within such ninety (90) day period, such Party takes reasonable steps to
commence and proceeds diligently thereafter to cure such default and, in fact,
cures such default within a reasonable period of time, or (iii) if such default
is cured in any other manner satisfactory to the other Party as a substitute for
full performance, then this Agreement will continue in full force and effect
until it expires as provided herein.
11.4 Termination for Bankruptcy,
etc. Either Party shall be entitled to terminate this
Agreement immediately:
(a) if
any creditor of the other Party or any other person levies or attempts to levy
any distress, execution, sequestration or other process over the business assets
of the other Party or an encumbrancer takes or attempts to take possession of
the business or assets of the other Party;
(b) if
a petition shall be presented for the winding up of the other Party or if a
meeting is convened for the purpose of passing a resolution for the winding up
of the other Party;
(c) if
a receiver, administrative receiver, manager, trustee or administrator shall be
appointed over all or any part of the business or assets of the other
Party;
(d) if
the other Party or any director or creditor of such other Party shall present a
petition to the court for an administrative order in respect of such other
Party;
14
(e) if
the other Party shall convene a meeting of its creditors or shall make any
proposal for or enter into any compromise, composition or scheme of arrangement
with its creditors or make any assignment for the benefit of its
creditors;
(f) if
the other Party shall be deemed to be unable to pay its debts within the meaning
of any relevant insolvency law or any relevant insolvency decree or regulation
(or any statutory amendment or reenactment thereof); or
(g) if
any event analogous to the foregoing shall occur under the laws of any relevant
jurisdiction.
11.5 Termination for
Failure. In the event Omnipharm fails to provide (a) the
necessary technical and regulatory batches needed for Product Registration in
the Territory for the Initial Products within the agreed to timeline in the
Development Plan; or (b) provide by December 31, 2008 (i) shelf life data under
accelerated conditions demonstrating **-month and **-month accelerated stability
for Product A and Product B and (ii) clinical efficacy of Product B, each from
an independent lab reasonably acceptable to Fidopharm, and reasonable
acceptability of **of Product A and Product B ** by Fidopharm based on
commercial viability of Products, Fidopharm shall have the right to terminate
this Agreement immediately and upon such termination Omnipharm shall reimburse
any payments made to it under this Agreement and one hundred percent (100%) of
the cost and expenses expended by Fidopharm to Develop, register and
commercialize Products in the Territory up to five hundred thousand dollars
($500,000), including all costs and expenses for obtaining the Product
Registrations (together with the upfront payment, the “Costs”); provided, that in
the event Omnipharm has accomplished (x) subsection (i) of Section (b) above,
the reimbursement shall be reduced by forty percent (40%) of the Costs, and/or
(y) subsection (ii) of Section (b) above, the reimbursement shall be reduced by
another forty percent (40%) of the Costs and/or (z) Section (a) above, the
reimbursement shall be reduced by another twenty (20%) of the
Costs.
11.6 Effect
of Expiration or Termination.
(a) No
expiration or termination of this Agreement pursuant to this Article 11 shall
relieve either Party of obligations accrued to such date of expiration or
termination or of obligations which continue by the terms hereof beyond such
expiration or termination, including, but not limited to, any payment
obligations hereunder. Articles 1, 9, 10 and 13 and Sections 2.4,
5.3, 6.2, 8.1, 8.2 and this Section 11.6 shall survive the termination or
expiration of this Agreement
(b) In
the event that this Agreement expires or is terminated pursuant to Section
11.2(b), 11.3 or 11.4 the licenses granted hereunder to Fidopharm shall become
irrevocable, royalty-free, non-exclusive licenses, with the right to grant
sublicenses, to market, promote and sell Products in the Field in the
Territory.
(c) Within
thirty (30) days following the termination of this Agreement, each Party shall
destroy, delete (as to Confidential Information stored in electronic format) or
return to the other Party all Confidential Information of the other Party, and
shall provide the other Party written certification of such destruction or
return.
(d) After
termination of this Agreement, Fidopharm shall cease using or selling Products
pursuant to the license grant herein (for clarity, the preceding shall not limit
Fidopharm’s rights pursuant to the licenses granted under Section 11.6(b));
provided, however, that Fidopharm may continue to sell in the ordinary course of
business for a period of twelve (12) months reasonable quantities of Products
which are manufactured and in Fidopharm’s normal inventory at the date of
termination; provided that such Product had been ordered in-line with
Fidopharm’s forecast.
15
(e) In
the event of termination of this Agreement by Fidopharm pursuant to Section
11.2(a), Fidopharm shall (i) transfer to Omnipharm all rights, title and
interests in and to the Product Registration and (ii) take such other steps
requested by Omnipharm, all of the foregoing at Omnipharm’s sole cost and
expense, to effect the transfer. Fidopharm will provide all
reasonable support, at Omnipharm’s reasonable cost, to facilitate the transfer
of such Product Registrations in a timely manner.
|
12.
|
INJUNCTIVE
RELIEF AND DISPUTE RESOLUTION
|
12.1 Equitable
Relief. Notwithstanding anything to the contrary in this
Agreement, either Party will have the right to seek temporary injunctive relief
or the ordering of specific performance in any court of competent jurisdiction
as may be available to such Party under the laws and rules applicable in such
jurisdiction with respect to any matters arising out of the other Party’s
performance of or failure to perform its obligations under this
Agreement.
12.2 Dispute
Resolution. In the event the Parties are unable to resolve any
controversy or claim arising from this Agreement (“Dispute”), the Parties will
submit such Dispute to arbitration under the rules of the American Arbitration
Association, as the same may be amended by mutual agreement of the
Parties. The Dispute shall be submitted to an expert panel in the
pertinent field for binding arbitration. Such expert panel may be
mutually agreed by the Parties, but if no such agreement is reached within ten
(10) days after the written notice from one Party to the other, then each Party
shall promptly select one expert, and those two (2) shall select a third expert,
the three (3) of whom shall comprise the expert panel. The
arbitrator(s) shall determine what discovery will be permitted, based on the
principle of limiting the cost and time which the parties must expend on
discovery; provided, the arbitrator(s) shall permit such discovery as they deem
necessary to achieve an equitable resolution of the dispute. Both
Parties will cooperate in providing fully to each other all requested
information and documents relating to the arbitration proceedings, except for
information and documents subject to any privilege. The place of any
arbitration proceedings shall be New York, New York or such other location as
the Parties may mutually agree. During the arbitration proceedings,
except for the matter that is in dispute and under arbitration, this Agreement
shall continue to be implemented by both Parties. Unless the expert
panel for good cause determines otherwise, each Party shall bear one-half of the
fees and expenses of the experts and shall bear its own costs and attorneys’
fees in connection with the arbitration proceeding; provided that the
arbitrator(s) may in their discretion award to the prevailing party the costs
and expenses incurred by the prevailing party in connection with the arbitration
proceeding. The decision and/or award rendered by the arbitrator(s)
shall be written, final and non-appealable and may be entered in any court of
competent jurisdiction. The provisions of this subsection shall not
prohibit either Party from seeking equitable relief to restrain any breach or
threatened breach of this Agreement at any time in any court of competent
jurisdiction as may be available to such Party under the laws and rules
applicable in such jurisdiction. The arbitral proceedings and all
pleadings and written evidence shall be in the English language. Any
written evidence originally in a language other than English shall be submitted
in English translation accompanied by the original or true copy
thereof.
|
13.
|
MISCELLANEOUS
|
13.1 Force
Majeure. Neither Party hereto shall be liable for damages, nor
shall this Agreement be terminable or cancelable by reason of any delay or
default in such Party’s performance hereunder (other than the payment of monies
due and owing to a Party under this Agreement) if such default or delay is
caused by acts of God, acts of public enemies, war or insurrection, civil
commotion, destruction of production facilities or materials by earthquake,
fire, flood or storm, epidemics, labor disputes or strikes, or failure of public
utilities (“Force
Majeure”). Each Party shall endeavor to resume its performance
hereunder as soon as reasonably possible if such performance is delayed or
interrupted by reason of Force Majeure.
13.2 Further
Assurances. Each of the Parties shall, from time to time
during the term of this Agreement, upon request by the other, execute and
deliver all such further documents or instruments as may be required in order to
give effect to the purpose and intent of this Agreement.
16
13.3 Assignment. Neither
Party shall assign this Agreement without the prior written consent of the other
Party, provided, that either Party may assign this Agreement without the prior
written consent of the other Party (a) to an Affiliate or (b) to a party in
connection with the sale or transfer of substantially all of its assets with
respect to the business to which this Agreement is related to such
party. Any permitted assignee shall assume all obligations of its
assignor under this Agreement. Any purported assignment in violation
of this Section 13.3 shall be void. No assignment shall relieve
either Party of responsibility for the performance of any accrued obligation
that such Party then has hereunder.
13.4 Choice of Law. This
Agreement shall be governed by, and construed in accordance with, the laws of
the State of Delaware, USA, without giving effect to its principles of conflicts
of laws. The Parties hereby submit to the exclusive jurisdiction of,
and waive any venue objections against, federal and state courts of competent
jurisdiction in the State of Delaware in any litigation or dispute arising out
of this Agreement. The prevailing party in any dispute or legal
action regarding the subject matter of this Agreement shall be entitled to
recover attorney’s fees and costs.
13.5 Notices. Any
notice, request or other communication required or permitted by this Agreement
to be given by any Party to another Party shall be in writing and either mailed
by registered or certified mail, return receipt requested, by express delivery
service or by facsimile transmission, addressed to such Party, Attention: the
Managing Director, at its address indicated in the preamble or to such other
address as such Party previously may have designated by like written
notice. Notice shall be deemed to have been given upon
receipt. Facsimile transmission numbers for the Parties are as
follows:
|
If to
Fidopharm:
Fidopharm,
Inc.
▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
▇▇▇▇▇▇
▇▇▇▇▇▇ of America
Attn:
▇▇▇▇ ▇▇▇▇▇▇▇
Tel:
Fax:
|
with a copy
to:
▇▇▇▇▇▇,
▇▇▇▇▇ & Bockius
▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇
▇▇, ▇▇▇▇▇
▇▇▇▇▇▇
▇▇▇▇▇▇ of America
Attn:
Fahd M.T. Riaz, Esq.
Tel:
(▇▇▇) ▇▇▇-▇▇▇▇
Fax:
(▇▇▇) ▇▇▇-▇▇▇▇
|
|
If to
Omnipharm:
Omnipharm
Century
House
15
/ ▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇
▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇
▇▇▇
▇▇▇
United
kingdom
Attn: ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇
Tel: ▇▇▇
▇▇▇▇ ▇▇▇▇▇▇
Fax: ▇▇▇
▇▇▇▇ ▇▇▇▇▇▇
|
with a copy
to:
Ashfords
▇▇▇▇▇▇▇
▇▇▇▇▇
▇▇▇▇▇▇▇▇▇
▇▇▇▇,
▇▇▇▇▇▇,
▇▇▇
▇▇▇
United
Kingdom
Attn:
▇▇▇▇ ▇▇▇▇▇▇
Tel: ▇▇▇
▇▇▇▇ ▇▇▇▇▇▇
Fax: ▇▇▇
▇▇▇▇ ▇▇▇▇▇▇
|
13.6 Entire Agreement. This
Agreement constitutes the entire agreement between the Parties with respect to
the subject matter hereof and supersedes all prior written or oral agreements or
understandings regarding the subject matter hereof or in conflict with its
terms, including but not limited to, the License and Development Agreement
entered into by the Parties on February 15, 2008. This Agreement will
be construed as if it were drafted jointly by the Parties and shall not be
strictly construed against either Party.
17
13.7 Amendments;
Waivers. No modification of any of the terms of this Agreement
shall be deemed valid unless it is in writing and signed by the Party against
whom such modification is sought to be enforced. The failure of
either Party to insist upon the strict performance of any term of this Agreement
or the waiver by either Party of any breach under this Agreement shall not
prevent the subsequent strict enforcement of such term nor be deemed a waiver of
any subsequent breach.
13.8 Severability. In
the event any court declares illegal or unenforceable, as written or applied,
any provision of this Agreement, such provision shall be severed and the
remaining provisions of this Agreement shall continue in full force and effect
as if such provision had been deleted or made inapplicable to the situations to
which such provision cannot be legally applied. The Parties shall use
their best efforts to agree upon a valid and enforceable provision as a
substitute for the severed provision, taking into account the intent of this
Agreement.
13.9 Independent
Contractors. Each Party is an independent contractor under
this Agreement. Nothing contained in this Agreement is intended nor
is to be construed so as to constitute Omnipharm or Fidopharm as partners or
joint venturers with respect to this Agreement. Neither Party shall
have any express or implied right or authority to assume or create any
obligations on behalf of or in the name of the other Party, or to bind the other
Party to any other contract, agreement or undertaking with any Third Party or
Affiliate.
13.10 Counterparts. This
Agreement may be executed by fax and in one or more counterparts, each of which
shall be deemed to be an original but all of which together shall constitute one
and the same instrument.
13.11 Headings. The
headings used in this Agreement have been inserted for convenience of reference
only and do not define or limit the provisions hereof.
***
Remainder of Page Intentionally Left Blank; Signature Page Follows
***
18
IN WITNESS WHEREOF, the
Parties hereto have executed this Agreement as of the Effective
Date.
|
/s/
▇▇▇▇ ▇▇▇▇▇▇▇
|
|
|
Name:
▇▇▇▇ ▇▇▇▇▇▇▇
|
|
|
Title:
President & CEO
|
|
|
OMNIPHARM
LIMITED
|
|
|
/s/
▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
|
|
|
Title:
CEO
|
19
SCHEDULE
1
**
20
SCHEDULE
2
Patents
No
Patents exist as of the Effective Date.
21
SCHEDULE
4.2
**
22